BD Diagnostic Systems
Country not established
- Devices
- 7
- FDA recalls
- 13
At a glance
Market reach
- United States
- FDA recalls
What BD Diagnostic Systems makes
Bd Diagnostic Systems manufactures automated microbiology systems for identifying bacterial and fungal infections, including the BD BACTEC FXI Culture System for isolating pathogens and BD PHOENIX Automated Microbiology Systems for antimicrobial susceptibility testing. Their product line also includes PASCO MIC and MIC/ID panels for antimicrobial resistance profiling, as well as the BD PrepStain System for sample preparation in microbiological diagnostics.
The company’s devices are regulated under FDA pathways, including 510(k) clearances for Class I and II products and Premarket Approval (PMA) for Class III systems. These products are listed in the FDA’s 510(k) and PMA registries, reflecting their authorised use in clinical microbiology laboratories. Bd Diagnostic Systems operates from the United States.
Catalogue
BD BACTEC FXI Culture System Ref K260213
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Pasco Mic And Mic/Id Panels Ref K032259
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
BD PrepStain System Ref P970018
Regimes: PMA Registry: PMA
FDA recalls
FDA recall records list 13 recalls initiated by Bd Diagnostic Systems, initiated on 2004-10-20. By recorded status: 13 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 20 Oct 2004 Z-0311-05 Unclassified (pre-2012) Terminated Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- 20 Oct 2004 Z-0312-05 Unclassified (pre-2012) Terminated Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- 20 Oct 2004 Z-0313-05 Unclassified (pre-2012) Terminated Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- 20 Oct 2004 Z-0314-05 Unclassified (pre-2012) Terminated Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- 20 Oct 2004 Z-0315-05 Unclassified (pre-2012) Terminated Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- 20 Oct 2004 Z-0316-05 Unclassified (pre-2012) Terminated Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- 20 Oct 2004 Z-0317-05 Unclassified (pre-2012) Terminated Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- 20 Oct 2004 Z-0318-05 Unclassified (pre-2012) Terminated Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- 20 Oct 2004 Z-0319-05 Unclassified (pre-2012) Terminated Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- 20 Oct 2004 Z-0320-05 Unclassified (pre-2012) Terminated Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Show all 13 recalls
2004
- 20 Oct 2004 Z-0321-05 Unclassified (pre-2012) Terminated Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- 20 Oct 2004 Z-0322-05 Unclassified (pre-2012) Terminated Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- 20 Oct 2004 Z-0323-05 Unclassified (pre-2012) Terminated Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Frequently asked questions
How many devices does Bd Diagnostic Systems have in the registry?
The registry currently lists 7 devices for Bd Diagnostic Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bd Diagnostic Systems's devices?
Among its 7 most recently registered devices, Bd Diagnostic Systems has devices listed in FDA 510(k) (6 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Bd Diagnostic Systems's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Bd Diagnostic Systems's devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Bd Diagnostic Systems?
FDA recall records list 13 recalls initiated by Bd Diagnostic Systems, the most recent initiated on 2004-10-20. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Bd Diagnostic Systems in the registry?
The most recently registered devices listed for Bd Diagnostic Systems include BD BACTEC FXI Culture System, BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML, PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) and BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML.